UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of anticoagulant treatment using New oral anticoagulant (edoxaban) in atrial fibrillation after cardiac surgery.
Acronym	Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in atrial fibrillation after cardiac surgery.
Scientific Title	Efficacy and safety of anticoagulant treatment using New oral anticoagulant (edoxaban) in atrial fibrillation after cardiac surgery.
Scientific Title:Acronym	Efficacy and safety of anticoagulant treatment using new alternative antithrombotic agents in atrial fibrillation after cardiac surgery.
Region	Japan

Condition
Condition	arterial fibrillation after cardiac surgery (nonvalvular disease)
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of anticoagulant treatment using New oral anticoagulant (edoxiaban) in arterial fibrillation after cardiac surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cerebrovascular and hemorrhagic event within 60 days
Key secondary outcomes	Hb,PT, APTT UCG(pericardial effusion)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	New oral anticoagulant (edoxaban) for patients with atrial fibrilation after cardiac surgery 30~60mg/day for 2 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	nonvalvular atrial fibrillation patients from whom informed consent was obtained
Key exclusion criteria	past of arrhythmia cardiogenic shock NYHA class IV congestive heart failure despite treatment sinus bradycardia at rest (<50/min) second -or third-degree AV block clinical hypothyroidism or hyperthyroidism Doctor's decision not to register to this regimen
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Sezai
Organization	Nihon University School of medicine
Division name	Department of Cardiovascular Surgery
Zip code	1738610
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3982-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	1st name Akira Middle name Last name Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Zip code	1738610
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3982-8111
Homepage URL
Email	asezai.med@gmail.com

Sponsor
Institute	Nihon University school of medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University School of Medicine
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
Tel	03-3972-8111
Email	asezai@med.nihon-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日大板橋病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	150
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 06 Month 01 Day
Date of IRB	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 02 Month 22 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 22 Day
Last modified on	2021 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024387